The Platform Trial In COVID-19 priming and BOOsting (PICOBOO): The immunogenicity, reactogenicity, and safety of licensed COVID-19 vaccinations administered as a second booster in BNT162b2 primed individuals aged 18-<50 and 50-<70 years old

被引：0

作者：

Mcleod, C. ^{[1
,2
,3
,4
]}

Dymock, M. ^{[1
,5
]}

Flanagan, Kl ^{[6
,7
,8
,20
,23
]}

Plebanski, M. ^{[8
]}

Marshall, Hs ^{[9
,10
,11
]}

Estcourt, Mj ^{[4
]}

Wadia, U. ^{[1
,2
,3
]}

Tjiam, Mc ^{[1
]}

Blyth, Cc ^{[1
,2
,3
,12
]}

Subbarao, K. ^{[13
,14
]}

Mordant, Fl ^{[14
]}

Nicholson, S. ^{[15
,16
]}

Cain, N. ^{[14
]}

Brizuela, R. ^{[14
]}

Faust, Sn ^{[17
,18
,19
]}

Thornton, Rb ^{[1
,3
]}

Ellis, Z. ^{[1
]}

Mckenzie, A. ^{[21
]}

Marsh, Ja ^{[1
,3
]}

Snelling, Tl ^{[4
]}

Richmond, Pc ^{[1
,3
,22
]}

机构：

[1] Wesfarmers Ctr Vaccines & Infect Dis, Kids Res Inst Australia, Nedlands, Australia

[2] Perth Childrens Hosp, Dept Infect Dis, Nedlands, WA, Australia

[3] Univ Western Australia, Ctr Child Hlth Res, Crawley, Australia

[4] Univ Sydney, Fac Med & Hlth, Sydney Sch Publ Hlth, Sydney, Australia

[5] Univ Western Australia, Sch Populat & Global Hlth, Nedlands, Australia

[6] Launceston Gen Hosp, Clifford Craig Fdn, Tasmanian Vaccine Trial Ctr, Hobart, Australia

[7] Univ Tasmania, Coll Hlth & Med, Sch Hlth Sci, Launceston, Tas, Australia

[8] Royal Melbourne Inst Technol RMIT Univ, Sch Sci, Melbourne, Vic, Australia

[9] Womens & Childrens Hlth Network, North Adelaide, Australia

[10] Univ Adelaide, Robinson Res Inst, Adelaide, Australia

[11] Univ Adelaide, Adelaide Med Sch, Adelaide, Australia

[12] QEII Med Ctr, PathWest Lab Med WA, Dept Microbiol, Nedlands, Australia

[13] WHO Collaborating Ctr Reference & Res Influenza, Parkville, Vic, Australia

[14] Univ Melbourne, Peter Doherty Inst Infect & Immun, Dept Microbiol & Immunol, Melbourne, Australia

[15] Royal Melbourne Hosp, Peter Doherty Inst Infect & Immun, Victorian Infect Dis Reference Lab, Melbourne, Australia

[16] Univ Melbourne, Peter Doherty Inst Infect & Immun, Dept Infect Dis, Melbourne, Australia

[17] Univ Hosp Southampton NHS Fdn Trust, Southampton Clin Res Facil, Natl Inst Hlth Res, Southampton, England

[18] Univ Hosp Southampton NHS Fdn Trust, Biomed Res Ctr, Southampton, England

[19] Univ Southampton, Fac Med, Southampton, England

[20] Univ Southampton, Inst Life Sci, Southampton, England

[21] Kids Res Inst Australia, Nedlands, Australia

[22] Perth Childrens Hosp, Gen Paediat Dept, Nedlands, WA, Australia

[23] Perth Childrens Hosp, Immunol Dept, Nedlands, Australia

来源：

JOURNAL OF INFECTION | 2024年 / 89卷 / 06期

基金：

澳大利亚国家健康与医学研究理事会;

关键词：

COVID-19; Vaccination; Adaptive trial; Policy; Immunisation; SARS-COV-2; VACCINES;

D O I：

10.1016/j.jinf.2024.106346

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Objectives: PICOBOO is a randomised, adaptive trial evaluating the immunogenicity, reactogenicity, and safety of COVID-19 booster strategies. Here, we present data for second boosters among individuals aged 18-<50 and 50-<70 years old primed with BNT162b2 until Day (D) 84. Methods: Immunocompetent adults who had received two doses of BNT162b2 and any licensed COVID-19 booster at least three months prior were eligible. Participants were randomly allocated to BNT162b2, mRNA-1273 or NVX-CoV2373 1:1:1. The log(10) concentration of anti-spike Ig Total was summarised as the geometric mean concentration (GMC). Reactogenicity and safety outcomes were captured. Results: Between Mar 2022 and Aug 2023, 743 participants were recruited to the trial and had D28 samples available. Of these, 120 and 103 belonged to the 18-<50 y and 50-<70 y strata, respectively. The mean adjusted GMCs (95% credible intervals) peaked at D28; these were 41 262 (31 611, 51 105), 45 585 (34 194, 57 441) and 25 281 (20 021, 31 234) U/mL in the 18-<50 y stratum and 30 753 (25 071, 36 704), 35 132 (27 523, 42 239) and 17 322 (13 983, 20 641) U/mL in the 50-<70 y stratum following BNT162b2, mRNA-1273 and NVX-CoV2373, respectively. Limited neutralisation against Omicron subvariants was found following boosting with all vaccines. There were 4 possibly or probably-related adverse events in the 18-<50 y stratum and 5 events in the 50-<70 y stratum, and severe reactogenicity events were <10% and <11% in these strata, respectively. Conclusions: Vaccines targeting Ancestral virus elicited boosted antibody responses to Ancestral virus but minimal neutralising antibody against Omicron variants. (c) 2024 Published by Elsevier Ltd on behalf of The British Infection Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

引用

页数：10

共 47 条

[31] Head-to-head analysis of heterologous ChAdOx1 nCoV-19-priming and BNT162b2 or mRNA-1273-boosting with homologous COVID-19 vaccine regimens including effects of a third booster dose
Klemis, V.
Schmidt, T.
Schub, D.
Mihm, J.
Marx, S.
Abu-Omar, A.
Ziegler, L.
Hielscher, F.
Guckelmus, C.
Urschel, R.
Wagenpfeil, S.
Schneitler, S.
Becker, S. L.
Gaertner, B. C.
Sester, U.
Sester, M.
EUROPEAN JOURNAL OF IMMUNOLOGY, 2022, 52 : 12 - 12
[32] Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years
Hu, Mao
Shoaibi, Azadeh
Feng, Yuhui
Lloyd, Patricia C.
Wong, Hui Lee
Smith, Elizabeth R.
Amend, Kandace L.
Kline, Annemarie
Beachler, Daniel C.
Gruber, Joann F.
Mitra, Mahasweta
Seeger, John D.
Harris, Charlalynn
Secora, Alex
Obidi, Joyce
Wang, Jing
Song, Jennifer
McMahill-Walraven, Cheryl N.
Reich, Christian
McEvoy, Rowan
Do, Rose
Chillarige, Yoganand
Clifford, Robin
Cooper, Danielle D.
Forshee, Richard A.
Anderson, Steven A.
JAMA NETWORK OPEN, 2024, 7 (04) : E248192
[33] Safety and Immunogenicity Following the Second and Third Doses of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents with Juvenile-Onset Autoimmune Inflammatory Rheumatic Diseases: A Prospective Multicentre Study
Heshin-Bekenstein, Merav
Ziv, Amit
Toplak, Natasa
Lazauskas, Siman
Kadishevich, Danielle
Yaari, Efrat Ben-Nun
Miller-Barmak, Adi
Aviel, Yonatan Butbul
Saiag, Esther
Pel, Sara
Elkayam, Ori
Uziel, Yosef
Furer, Victoria
VACCINES, 2023, 11 (04)
[34] Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial
Munro, Alasdair P. S.
Janani, Leila
Cornelius, Victoria
Aley, Parvinder K.
Babbage, Gavin
Baxter, David
Bula, Marcin
Cathie, Katrina
Chatterjee, Krishna
Dodd, Kate
Enever, Yvanne
Gokani, Karishma
Goodman, Anna L.
Green, Christopher A.
Harndahl, Linda
Haughney, John
Hicks, Alexander
van der Klaauw, Agatha A.
Kwok, Jonathan
Lambe, Teresa
Libri, Vincenzo
Llewelyn, Martin J.
McGregor, Alastair C.
Minassian, Angela M.
Moore, Patrick
Mughal, Mehmood
Mujadidi, Yama F.
Murira, Jennifer
Osanlou, Orod
Osanlou, Rostam
Owens, Daniel R.
Pacurar, Mihaela
Palfreeman, Adrian
Pan, Daniel
Rampling, Tommy
Regan, Karen
Saich, Stephen
Salkeld, Jo
Saralaya, Dinesh
Sharma, Sunil
Sheridan, Ray
Sturdy, Ann
Thomson, Emma C.
Todd, Shirley
Twelves, Chris
Read, Robert C.
Charlton, Sue
Hallis, Bassam
Ramsay, Mary
Andrews, Nick
LANCET, 2021, 398 (10318): : 2258 - 2276
[35] Plain language summary of Pfizer-BioNTech BNT162b2 vaccine protection against COVID-19 and its safety in participants 12-to 15-years-old
Frenck Jr, Robert W.
Klein, Nicola P.
Kitchin, Nicholas
Gurtman, Alejandra
Absalon, Judith
Lockhart, Stephen
Perez, John L.
Walter, Emmanuel B.
Senders, Shelly
Bailey, Ruth
Swanson, Kena A.
Ma, Hua
Xu, Xia
Koury, Kenneth
Kalina, Warren, V
Cooper, David
Jennings, Timothy
Brandon, Donald M.
Thomas, Stephen J.
Tureci, Ozlem
Tresnan, Dina B.
Mather, Susan
Dormitzer, Philip R.
Sahin, Ugur
Jansen, Kathrin U.
Gruber, William C.
FUTURE VIROLOGY, 2023, 18 (01) : 9 - 20
[36] Immunogenicity and safety in healthy adults of full dose versus half doses of COVID-19 vaccine (ChAdOx1-S or BNT162b2) or full-dose CoronaVac administered as a booster dose after priming with CoronaVac: a randomised, observer- masked, controlled trial in Indonesia
Fadlyana, Eddy
Setiabudi, Djatnika
Kartasasmita, C. B.
Putri, Nina Dwi
Hadinegoro, Sri Rezeki
Mulholland, Kim
LANCET INFECTIOUS DISEASES, 2023, 23 (05): : 545 - 555
[37] Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Results from an active pharmacovigilance study in central Italy
Ripabelli, Giancarlo
Sammarco, Michela Lucia
D'Amico, Antonio
De Dona, Roberta
Iafigliola, Mariagrazia
Parente, Albino
Samprati, Nicandro
Santagata, Arturo
Adesso, Carmen
Natale, Anna
Di Palma, Michela Anna
Cannizzaro, Fabio
Romano, Roberto
Licianci, Antonietta
Tamburro, Manuela
HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2022, 18 (06)
[38] Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial
Lazarus, Rajeka
Baos, Sarah
Cappel-Porter, Heike
Carson-Stevens, Andrew
Clout, Madeleine
Culliford, Lucy
Emmett, Stevan R.
Garstang, Jonathan
Gbadamoshi, Lukuman
Hallis, Bassam
Harris, Rosie A.
Hutton, David
Jacobsen, Nick
Joyce, Katherine
Kaminski, Rachel
Libri, Vincenzo
Middleditch, Alex
McCullagh, Liz
Moran, Ed
Phillipson, Adrian
Price, Elizabeth
Ryan, John
Thirard, Russell
Todd, Rachel
Snape, Matthew D.
Tucker, David
Williams, Rachel Lauren
Nguyen-Van-Tam, Jonathan S.
Finn, Adam
Rogers, Chris A.
LANCET, 2021, 398 (10318): : 2277 - 2287
[39] Longitudinal safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine in children aged 4-11 years with juvenile-onset autoimmune inflammatory rheumatic diseases: A prospective multicenter study
Eviatar, Tali
Ziv, Amit
Oved, Amir
Miller-Barmak, Adi
Pappo, Adi
Livny, Ruth
Amarilyo, Gil
Aviel, Yonatan Butbul
Naor, Rinat
Pel, Sara
Furer, Victoria
Elkayam, Ori
Uziel, Yosef
Heshin-Bekenstein, Merav
VACCINE, 2024, 42 (26)
[40] Safety and Immunogenicity of Concomitant Administration and Combined Administration of Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine with or Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age
Neutel, Joel M.
Erdem, Rahsan
Jiang, Qin
Cannon, Kevin
Stacey, Helen
Newton, Ryan
Gomme, Emily
Li, Wen
Mensa, Federico J.
Tureci, Ozlem
Sahin, Ugur
Swanson, Kena A.
Munjal, Iona
Cooper, David
Koury, Kenneth
Anderson, Annaliesa S.
Gurtman, Alejandra
Kitchin, Nicholas
VACCINES, 2025, 13 (02)

← 1 2 3 4 5 →